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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MERGE HEALTHCARE MERGE HEMODYNAMICS PROGRAMMABLE DIAGNOSTIC COMPUTER

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MERGE HEALTHCARE MERGE HEMODYNAMICS PROGRAMMABLE DIAGNOSTIC COMPUTER Back to Search Results
Model Number MERGE HEMODYNAMICS 10.0.1
Device Problem Computer Software Problem (1112)
Patient Problem Myocardial Infarction (1969)
Event Date 03/08/2016
Event Type  malfunction  
Manufacturer Narrative
Remote diagnostic testing was performed on the customer's hemo software, and sfc (system file checker) found corrupt windows files that could not be repaired as well as adobe errors. These have been attributed to the windows speech recognition feature. The customer was sent a thumb drive containing merge installer so the hemo client could be re-imaged. On 3/17/2016, the client computer was re-imaged. Subsequent remote diagnostic testing did not find any of the pre-existing warnings or errors. However, the customer was asked to complete more test studies using domain log-ons since the issue was intermittent to ensure the issue has been fixed. The problem is currently under investigation ((b)(4)). A follow-up report will be submitted with the results of the investigation when it is complete.
 
Event Description
Merge hemodynamics monitors, measures, and records physiological data from a human patient undergoing a cardiac catheterization procedure. The system comprises the patient data module and the hemodynamics hemo monitor pc. The two units are connected via a serial interface. All vital parameters and evaluations are registered and calculated in the patient data module. This data is then transmitted to the hemodynamics hemo monitor pc via the serial interface. All data can be shown and monitored on the hemodynamics hemo monitor pc. On (b)(6) 2016, a customer reported to merge healthcare that the hemo application froze during an emergent intervention case for a patient with myocardial infarction resulting in the procedure being delayed 5-7 minutes. The patient came from the er, was intubated, on a respirator, and the bp was 65. It was further reported that the patient's waveforms were displayed; however, there was no capability to measure or sample pressures. The medical staff used an impella catheter by which the patient's pressures could be measured and to provide partial circulatory support for the patient. The customer further reported that the ultimate outcome of the patient's condition was currently unknown. With merge hemo not presenting physiological data during treatment, there is a potential for a delay in care that results in harm to the patient. However, it was indicated that the heart catheterization procedure was completed successfully by means of using the impella catheter. (b)(4).
 
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Brand NameMERGE HEMODYNAMICS
Type of DevicePROGRAMMABLE DIAGNOSTIC COMPUTER
Manufacturer (Section D)
MERGE HEALTHCARE
900 walnut ridge drive
hartland WI 53029
Manufacturer (Section G)
MERGE HEALTHCARE
900 walnut ridge drive
hartland WI 53029
Manufacturer Contact
meg mucha
900 walnut ridge drive
hartland, WI 53029
2623670700
MDR Report Key5562184
MDR Text Key42155114
Report Number2183926-2016-00534
Device Sequence Number1
Product Code DQK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K082421
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation
Remedial Action Recall
Type of Report Initial,Followup
Report Date 03/08/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/08/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMERGE HEMODYNAMICS 10.0.1
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received04/16/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/12/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Removal/Correction NumberZ-1091-2017

Patient Treatment Data
Date Received: 04/08/2016 Patient Sequence Number: 1
Treatment
IMPELLA CATHETER
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